Zimmer Biomet Gains FDA Clearance for ROSA Knee System

By Julie A. Vetalice

Zimmer Biomet received FDA 510(k) clearance to market the ROSA® Knee System for robotically-assisted total knee replacement.

ROSA Knee uses proprietary X-Atlas™ imaging protocol, which provides x-ray based pre-op imaging to create a 3D model and plan of a patient's bone anatomy.

As noted in the company's 3Q18 earnings call, the first five ROSA knee cases were completed in a single surgery day by one physician, perhaps hinting at the company’s positioning of their robot as efficient and minimally disruptive to procedure flow.

Analysts note that the application for the spine indication has also been filed, and expect that clearance is pending.

Sources: Zimmer Biomet, Inc.; ORTHOWORLD Inc.

Product Labels: Knee Replacement

Tags: 510(k) Clearance, Regulatory